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OneOncology · 1 day ago

Research Regulatory Coordinator

TNO - GHCR Admin | Nashville, TN

Full-time

Onsite

New Grad, Entry Level

OneOncology is a leading community-based cancer care specialist committed to providing high-quality cancer care and clinical research expertise. The Research Regulatory Coordinator will support regulatory best practices, manage departmental correspondence, prepare regulatory documents, and ensure compliance with IRB submissions among other responsibilities.

Health CareOncology

Growth Opportunities

Responsibilities

Manage, date and distribute all incoming departmental correspondence

Prepare regulatory file folders, both paper if required and electronic for all new studies

Prepare initial regulatory packet to Sponsor (signature pages, 1572, CV’s, licenses, laboratory certifications, normal ranges, etc.)

Complete and obtain signatures on Protocols, Amendments and Investigator’s Brochures from appropriate personnel

Maintain and ensure up-to-date CV’s, licenses, laboratory certifications, normal ranges, etc

Complete and maintain Financial Disclosure forms for all studies

Complete and maintain Delegation of Authority Logs and FDA Form 1572

Prepare, obtain appropriate signatures and maintain Confidentiality Agreements

Assist in the completion of feasibility questionnaires, in addition to obtaining appropriate data from Investigator and study coordinator. Set up Pre-Study Visits and Site Initiation Visits including communication, sign-in sheets, ensuring availability of any Investigator or other department staff

Review Site Initiation Visit binders provided by Sponsors and distribute documents to appropriate team members

Ensure IRB submission, consent review/changes, IRB correspondence for new and amended protocols

Maintain IRB required dates for reviews and amendments

Process IND Safety reports, SUSAR reports and other interim safety reports per SOP

Prepare for monitor visits by ensuring files prepared and available for questions from monitors, etc

Process local SAE reports, with assistance from study coordinator/data management team, for regulatory files and submit to IRB

File protocol specific training documentation for all studies

Review and file incoming monitor letters. Correspond outstanding tasks with study coordinators

Report protocol deviations/waivers to IRB when applicable

Update Study Tracker as needed

Communicate with study coordinators about protocol updates/amendments and consent changes

Qualification

Regulatory best practicesMedical terminologyData collectionResearch knowledgeBachelor’s degree

Required

Bachelor's degree in life sciences or equivalent years of service

Working knowledge of medical and pharmaceutical terminology

Data collection experience

Research knowledge

Company

OneOncology

OneOncology is a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the US. It is a sub-organization of General Atlantic.

Founded in 2018